I’ll be joining Andrew von Eschenbach, chairman of Project FDA and former FDA commissioner and former director of the National Cancer Institute at the National Institutes of Health; Paul Howard, a senior fellow at the Manhattan Institute and director of its Center for Medical Progress (parent of Project FDA); and Peter Huber, Manhattan Institute senior fellow and author of the forthcoming book, The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. Also participating will be researchers, former FDA regulators, and representatives from innovative life sciences companies, patients’ groups, and the media.

I’m honored to be in such august company and to be asked to help solve this critical problem that affects every one of us. I’ll be talking about how the digitization and rapid sharing of clinical-trial and other health-care data can be used to speed up drug discovery and development — something I’ve written a lot about in the past.

It’s no secret that the clinical trials process is an enormously expensive and time-consuming part of bringing therapies to market with FDA approval, with Phase 3 clinical trials — final testing for effectiveness on large groups of patients — particularly onerous. This terrific editorial, by Dr. von Eschenbach and Tomas J. Philipson, explains why the clinical trials process is broken and why modernizing it, using digital technologies, will not only save lives but also jump-start the US economy.

I firmly believe that we can use technology to help modernize the clinical trials process to satisfy the FDA and payors’ goals of safety and efficiency and pharmaceutical companies,’ physicians’ and patients’ needs for expedience.

Using digital technologies, we can create new levels of information liquidity, transparency and fluidity among physicians, patients and regulators. We can create amazing advancements in bench-testing, field data collection, and data analytics that complement the amazing advancements we’ve seen in molecular medicine. With the right digital technologies, we can afford to create medicines that serve smaller patient populations, for whom there had been little or no hope in the past due to cost.

We just need to think differently and apply the technologies that are mainstream on the World Wide Web today — and to get started…TODAY.

Updated May 16, 2013: Here’s a video of the panel that I participated in: “Precision Medicine in a Digital World: Matching Patients and Therapies.” Other videos from the conference are available here.

Originally published at koablog.wordpress.com on May 1, 2013.

Project FDA: Bringing the FDA into the 21st Century was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

In keeping with our operating philosophy of providing places for founders to build great companies along the Red Line, we’re opening a new space around the block from our current digs. Located on the second floor of 66 Church Street, it’s right above the Market in the Square ― which is open 24 hours a day to help fuel the late nights our companies put in. I’m psyched to have some great companies joining us, including pushpage, OmniLync, Main Street Partners, Data-Tamer, Proximate and Fetchnotes.

My friend Hugo at Harvard’s Experiment Fund is helping us to design the space, bring in great Founders, and connect Koa with the immense intellectual capital at Harvard. I’m pumped to be creating an awesome space with him and the X-Fund so close to the ivy-gilded walls of Harvard. Harvard has evinced a long term commitment towards support entrepreneurism and this partnership is a great step towards building a Founder’s Culture in the Square.

There is no better place in the world to build a great, independent company than Cambridge. Koa and the X-Fund are going to provide a great complement to spaces like the CIC and structured incubators like Techstars and MassChallenge. As the huge demand for space shows, this is the best time in nearly two decades to start companies and I’m thrilled to do my part to help.

You may know I’m a bit of a rugby maniac. I’m affectionately nicknaming the space on the 6th floor of College House “Kiwi” after my favorite rugby team in the world, the New Zealand All-Blacks. The new space has earned the nickname “Springbok” after South Africa’s tremendous rugby team ― respecting Hugo’s home country.

Dedicated desks currently rent for $600 each, but cheaper part time and user agnostic desks are coming soon!

Make sure to drop by the Start-Up Common Room to hang out with us. Don’t forget to follow this blog and check out our Facebook page to stay up to date on the great Founders at Koa!

For more info, email Kelsey.cole@koalab.com

This entry was posted in Entrepreneurship, Innovation, Start-Ups.

Originally published at koablog.wordpress.com on April 1, 2013.

Introducing Koa Labs Start-Up Common Room was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

How a Two-Year Gig turned into a Four-Year Journey, For All the Right Reasons

Four years ago, Remy Evard and Brent Sanders came to visit Amy and me at our place in New Castle, NH. It was snowing and I remember thinking that these guys were crazy to drive all the way up to New Castle from Boston with a big snow storm rolling in. They insisted that they needed to talk to me about a unique opportunity.

They were both working at Novartis and wanted to talk about building great systems for scientists doing drug discovery and development. While I never imagined I’d work for a large Swiss biopharmaceutical company, I was on painkillers for a recently broken leg so they caught me at a weak moment 😉 I also felt that I wanted to exercise some of the work that we had started in the early 2000s when we started Infinity Pharmaceuticals: building great systems and software for biologists, chemists and clinicians doing drug discovery and development.

Almost four years to the day after our meeting in NH, Remy, Brent and I found ourselves at Tory Row in Harvard Square having a party to celebrate and wrap up my stint as the Global Head of Software and Data Engineering at the Novartis Institutes for Biomedical Research (NIBR). I officially handed the reins of our Engineering group to Ken Robbins that week. Ken is a crazy-talented engineering leader who I trust deeply to lead the next phase of development of software and data engineering at NIBR. Ken, thanks for taking the lead at NIBR Engineering.

There were many ups and downs through my four years at NIBR. But in retrospect, I had a lot of fun, got to work with some fantastic people, and made some great new friends. I hope that I made a contribution to NIBR’s mission: to deliver important new medicines to patients in need.

At NIBR in Cambridge, Mark Fishman, Dan Vasella and the team at Novartis have created a truly incredible organization. While many other large biopharmaceutical companies have abandoned large-scale biopharmaceutical research, Mark and the team have doubled down on research at NIBR, with strong support from Basel. Headquartered in Cambridge, Mass., NIBR has delivered fantastic results: Novartis has the best pipeline of any large biopharmaceutical company in the world and was ranked as the most admired company in the pharmaceutical industry in 2012.

NIBR has delivered fantastic results: Novartis has the best pipeline of any large biopharmaceutical company in the world.

The Information Technology organization at NIBR has been through a radically positive transformation over the past seven years with Remy Evard at the helm as CIO. As a serial entrepreneur, I can only survive in organizations that value innovation. The fact that I was at NIBR for four years ― on what was SUPPOSED to be a two-year gig ― is a testament to the quality of leadership and commitment to innovation, which today remain stronger than ever at NIBR IT. The fact that they didn’t fire me is a testament to my HR partners Petra Battersby and Carol Maszeroski, who did a fantastic job of keeping me out of trouble. Thanks, Carol and Petra 🙂

How did a two-year gig turn into a four-year journey? It boils down to four points:

1. NIBR has an important mission that is worth working towards: making a difference in the lives of patients by discovering important new medicines.
2. There is a critical mass of exceptional people at NIBR ↼ some of the best in the world ― especially at the bench. NIBR is the place for the best young scientists to work on the most important new medicines. Two of my favorite people include Andreas Loew and John Tallarico ↼ I’ll miss working directly with you guys 🙂
3. There is a culture of innovation at NIBR that recognizes (sooner or later) those people who believe that there is always a better way and room for improvement.
4. NIBR is committed to the strategic role of information and technology in drug discovery and development and is committed to hiring the best tech people.

I believe we made some great progress in terms of “webification” of the environment at NIBR, and the DevOps infrastructure at NIBR is truly state of the art. We also made great strides in the adoption of cloud tech. But, perhaps most importantly, the people in the engineering, high performance computing and informatics organizations are world-class. Discovering and developing important new drugs takes many decades and billions of dollars ― and building systems for scientists presents fundamental challenges, both organizational and technical ↼ but if anyone can figure it out at scale, it’s the team at NIBR IT.

More than ever, the Enterprise ↼ particularly biopharmaceutical companies ↼ needs to embrace web and cloud technologies at a radical pace.

I’m convinced now more than ever that the Enterprise ↼ particularly biopharmaceutical companies ↼ needs to embrace web and cloud technologies at a radical pace. The capabilities and efficiencies of web- and cloud-based infrastructure are radical, but most enterprises are holding onto client/server computing and shared memory/shared disk infrastructure because it’s what they know. But the time has come to burn the ships and leverage the discontinuous innovation and cost benefits that the consumer Internet companies have pioneered. All it takes is:

I would like to thank everyone who worked with me at NIBR for their time, patience and help ― especially my partners on the scientific leadership team. I hope I made a difference for you ― you are my heroes.

Thanks also to the team of people that worked directly for me and put up with my lack of patience, my difficult style, my inconsistent schedule and my propensity to “ready, fire, aim.” Specifically, thanks to :

John Walker
David Twomey
Sarah McNamara
Jason Calvert
Rachael Acker
William Wechtenhiser
Carty Castaldi
Steve Litster
Joseph Jonas
Chris Farnham
Heather Hook

You guys are the best.

I’d also like to thank Steve Cleaver, Patrick Warren, Pascal Afflard, Zuzana Foldes, Remy Evard, Brent Sanders and Greg Wolf and for their partnership over the past four years.

I hope that you guys will come over and hang out with me at Koa Lab ― and always know that I’m only a Google Hangout away 😉

Photo of NIBR Cambridge by Novartis AG, Some Rights Reserved.

Originally published at koablog.wordpress.com on March 26, 2013.

Building Systems for Scientists at NIBR was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

Should colleges or universities of the liberal arts and science disappear through irrelevance? Are they obsolete? Worry exists among some Deans and Presidents. But yet, do these institutions have a new, ever more important role for insuring our future?

Joel Mokyr, Professor of Economic History at Northwestern University, argues that while useful knowledge matters, we often forget our political, social, material, and cultural riches were built over a thousand years on a foundation of intellectualism, skepticism and creativity[i].

The printing press helped to disseminate knowledge and make it useful. The clock’s invention forced consideration of the flow of time. The Renaissance and Enlightenment stimulated know-how and movement toward democratic political systems. Montaigne asked “what do I know.” Newton celebrated standing on the shoulders of giants. Locke and Kant knew we could reason. Progress occurred not just because of technical breakthroughs. No, we could also think, broadly and with insight.

We thought about many things. Indeed, some of the greatest thinkers were able to do so across many disciplines. The ability to bridge seemingly unrelated concepts often was catalyst for change. Reading, listening and talking created a marketplace of ideas, where we solved problems and moved forward.

Yes, engineering and technical tinkering were needed to complement the discoveries within art and science. Nevertheless, the latter fields were necessary to gain understanding, to see nuance, to assess risk, or to stop totalitarianism. The world of books and education provided inter-generational connectedness. We looked to the past and wished to insure the future.

All through an effort to deal with uncertainty and enhance our judgment.

Enter the age of analytics and big data. Statistical confidence intervals have shrunk nearly to nothing. Now, all of humanity is at our fingertips. Almost, those who are in the know see through walls, to our most personal activities, to our behavior, to our desires, to our vices. Analytics and big data offer one more wave of technological “eureka!” that enables more people to be fed, clothed, moved, healed, or entertained. Big data is x-ray vision simultaneously capable of producing opportunity beyond our wildest dreams and contributing to our most horrific nightmares.

And what shall we do?

Pressure is immense to obtain jobs and careers through technical education, at the expense of broad learning within the liberal arts and sciences. Irrelevant is a word often used as a description. But is it?

Doesn’t the rise of analytics and big data create a new opportunity for broader study? After all, among many other socioeconomic fields, big data is touted as relevant in health care, transportation, manufacturing, government, pharmaceuticals, or education. Is not each of these an arena where ethics, privacy, interpretation, judgment remain important? Are not these the same arenas where the study of the liberal arts and science mitigated tremendous risks because those who were suitably trained saw danger where others did not? Are not these arenas where opportunities developed because those trained in the liberal arts and sciences possessed a perspective capable of seeing across boundaries and asking, “why not?”

Most of all, is it not true that while many entrepreneurs were technicians at the beginning, they came to see the value of diverse thinking and the need to live with change and competition?

Big data and analytics reinvent liberal arts and science colleges and universities, but not because of any newfangled way to teach. Change in teaching systems will always occur. No! Reinvention occurs because again, 500 years later after the printing press and 800 years after the development of the mechanical clock, the vital contributions of the liberal arts and sciences to humanity are needed, desperately.

If allowed to fail, if students are not introduced to worlds beyond their technical or narrow majors, if society does not reap the benefits of thoughtful and deep reasoning, but instead only to worship the onrushing tsunamis of data, then we risk an Orwellian world, dominated by Big Brother or big corporation or big wealth.

Colleges and universities of the liberal arts and sciences must change their ways, yes. However, it is only to acknowledge that every single discipline must contribute to the intelligent use of big data and maximize its potential. At the same time, every single discipline must teach itself about big data and analytics. Joel Moykr also celebrated “the Lever of Riches.”[ii] A lever works because of complementary components and action working together. Knowledge and judgment are important levers to technical progress and resulting riches. Let’s use them, not abandon them.

•••

Michael Donovan is Associate Professor of Business and Economics at Cedar Crest College in Allentown, Pennsylvania. He places special attention on the role of liberal arts and science in business decision-making. In addition to advanced studies in public policy, he holds degrees from Bowdoin College and the Columbia Business School. He had worked for the Bank of Boston, Data General Corporation, and AT&T before pursuing a mid-career change to economic and urban development policy and higher education, which includes a four-year term with the City Council of Allentown, Pennsylvania, the state’s third largest city. Professor Donovan may be reached at Mdonovan(at)cedarcrest(dot)edu.

[ii] Mokyr, J. (1990). The Lever of Riches: Technological Creativity and Economic Progress. Oxford University Press: New York.

***

* Thanks to Michael Donovan for sharing this insightful and thought-provoking post with the Koa Lab Blog as a guest blogger. Michael hired me into my first internship at Bowdoin. He opened his home, his family and his mentorship to me and established an expectation of giving back to others that has always served as a powerful role model for me in my career and my life. — Andy Palmer

Originally published at koablog.wordpress.com on March 12, 2013.

Liberal Arts and Sciences in the Age of Analytics was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

Our new space in Harvard Square is called Koa Lab Start-Up Club. It’s tucked into the top floor of the historic College House building, right next to Otto’s Pizza.

Our founding members are a diverse group of companies and people in different stages of invention, from well-known start-ups like Recorded Future to new ventures like Resurety, Matter.io and Data-Tamer. We also have a bunch of Founders that are just hanging out.

If you know me, you know that I’m crazy passionate about innovation and that I’m addicted to start-ups. I’m happiest (professionally speaking) when working with scary-smart people who are starting world-beating companies and operate with a commitment to capital efficiency. I also have an inherent tendency to break things, which can be a virtue in start-ups where risk taking is required and where there is a high tolerance for making lots of mistakes very quickly. So Koa is a safe place to break things 😉

Koa is a place for Founders↼ full stop. I agree strongly with Brad Feld’s hypothesis that the development of entrepreneurial communities needs to be inclusive of all but led by entrepreneurs. Koa is a place to start companies, hang out with smart people, have fun and take risks. The best entrepreneurial communities are fiercely inclusive and Feeders are incredibly important, but I believe that in Boston/Cambridge we’ve lacked an emphasis and priority on the development of Founders as the innovators and leaders in our community. As my good friend Eric Paley says all the time, young Founders are the heroes of our community, and we need to hold them up and do whatever it takes to make them successful.

At Koa, I wanted to create a shared space where inventors and entrepreneurs could get their ideas off the ground, starting from scratch. I wanted a place right in the hub of Harvard Square that’s affordable ↼ I don’t make any profit on the space, I just pass through the costs ↼ like a co-op.

We also wanted to provide a place for Founders to hang out without the unintentional but often-stifling “systematization” that occurs in larger incubators or VC firms. We want to keep it small; we’re not going to have a ton of space or large-scale or structured programs. There are plenty of places to go for that: my good friend Tim Rowe has done a first-rate job at the world’s best and most successful incubator, the Cambridge Innovation Center . I expect many companies to start at Koa and move to CIC and other spaces during the first couple of years of their development.

Why the name? “Koa” is Maori for “happiness,” but it also refers to “Koa Tree,” which is a tree that is indigenous to Hawaii and grows incredibly fast. In Hawaiian, “koa” also means “bold,” “brave,” “fearless,” and “warrior.” At Koa we like people who like to have fun, are brave, and want their companies and ideas to grow incredibly fast (most of us at Koa are inherently impatient). We also believe that starting companies is a team sport; hence the “Start-Up Club.” We believe that the best companies develop teamwork as a fundamental value, like we did very intentionally during the start-up process at Infinity Pharmaceuticals. Infinity remains a great example of the kind of strong culture required to create great new independent companies in Cambridge and Boston.

For another photo of Koa Lab, check out this article by Scott Kirsner of The Boston Globe, who visited Koa back in early December right after we opened.

With the move to my new digs, my personal blog, “The Fundable,” becomes the Koa Lab Blog. You’ll find all the previous content from The Fundable here, plus new content about starting, building and growing start-ups. Please bookmark the blog, comment on my posts, and let me know what you’d like me to talk about.

Find Koa Lab here and check us out on Facebook and LinkedIn.

Originally published at koablog.wordpress.com on March 5, 2013.

Hanging Out at Koa Lab was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

As frequent attendees of mobile health conferences, we’ve been excited by the momentum and creativity we’ve seen in mobile health solutions (Health Apps). But we’ve also been concerned.

We’re excited because of the number of Health Apps being developed for patients and consumers in different disease areas, for wellness, prevention and care. As big believers in the potential of Health Apps to improve outcomes and lower healthcare costs, we’re glad to see this market really take off.

At the same time, it seems there’s an App for everything — and anything. Yet there’s very little talk of interoperability or data exchange — heck, even about preserving my personal health data when I want to exchange my App for a new one, when I need to re-image my phone, or when I want to buy a new phone.

It seems like in the rush to capture the value of mHealth, we’re launching and creating a staggering amount of new health data silos — making health data less liquid and shareable when we need just the opposite. This is a big concern, because in the longer term, data liquidity is the key to sparking innovation, improving outcomes, and reducing healthcare costs.

At the recent 2012 mHealth Summit, it was encouraging to see that this approach is starting to shift. It seems that more and more healthcare companies are recognizing that even though their patients or their customers need these Apps, perhaps jumping head-first into Apps development isn’t their best bet. Instead, maybe healthcare companies should let “the market” develop these Apps (they seem to know what they’re doing!) while they support the market — with funding, with infrastructure, and with content (liquid data).

Getting It Right

One of the great examples at mHealth Summit was presented by Aetna, a 160-year-old health insurance company. Rather than joining the Apps Race, Aetna has developed and published the CarePass platform. The platform provides a set of APIs that allows you to build your own Apps, plus it provides interoperability among your App and all the other Apps developed using CarePass — including the 20+ Apps that Aetna has developed and acquired itself, such as iTriage. Update of January 24, 2013: Check out this great video interview with Aetna Vice President Martha Wofford.

AT&T and Qualcomm Life also presented their platforms, with APIs that connect to a variety of different health and wellness devices. These APIs allow you to build Apps that connect to these devices, yet also thereby become independent of the devices. For example, you could switch from one fitness sensor to another, buy a different wireless weight scale, or use a new blood-pressure monitor while the App preserves your health data.

Entirely in the same vein, earlier this year Athena Health, the Watertown, Mass-based provider of cloud-based Electronic Health Record (EHR) systems, launched their “More Disruption Please” program. Participants in the program receive access to the API of Athena Health’s EHR system, a platform to build Apps. They can even get access to start-up funding and launch support for their Apps in the network of Athena Health customers.

Allscripts launched a similar developer program for their EHR. And in 2009 Cerner launched its uDevelop platform, providing their customers with a platform and APIs to develop new Apps, and an App store to share these Apps with each other.

Of course, the largest, and perhaps most influential, organization to get it right is the ONC, which has been setting the tone for improving data liquidity in healthcare, and thereby stimulating healthcare innovation in Health Apps development, through an array of policies and programs. These include health information exchanges, meaningful use criteria for EHR adoption, Project Blue Button, and the Health Data.gov platform — to name just a few.

Many of these programs also provide funding for you to develop Apps with their APIs. And, if not, there is always Health 2.0, which announced in May 2012 that it had already awarded more than $1 million to mobile health initiatives through its Developer Challenge series.

Where to Go from Here

There will always be a new App, a better App, an App that fits my health needs better as they evolve over time — and that’s OK. Yet all this tremendous activity and investment in Health Apps will only really and truly pay off, for individuals and their individual health needs as well as for a sustained impact on the healthcare system overall, if those Apps are built on, and contribute to, an underlying layer of liquid health data.

As patients and consumers, we need to be able to switch from one device to the other, carry our health data from one provider to the other, switch insurance companies as we take new jobs, exchange one App for the other and so on — as our personal healthcare needs evolve over time. And those personal healthcare needs will really and truly only be served if our health data moves with us, as opposed to being caught in the latest fad and locked in the latest App.

For mHealth to pay off, we need APIs more than we need Apps. It’s great to see that so many companies are getting it right. A year ago, we felt both excited and concerned at the prospect of mHealth. Today, we’re just pumped.

Originally published at koablog.wordpress.com on December 14, 2012.

mHealth and Data Liquidity was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

In my last several posts, I wrote about how crucial it is to increase the liquidity of clinical research data ― particularly clinical trial data ― and how we can achieve improved data liquidity with patient-centric systems and software.

But there’s a remaining ― and not insignificant ― challenge: patient consent.

Before sharing their health information, people want to know it’s going to be secure and beneficial to do so. Until you’ve got people who are willing to share their data, it’s tough to justify the investment in building secure systems. A classic chicken-and-egg problem.

This is a very similar dynamic to e-commerce back in the 1990s. People were afraid to enter their credit card numbers into a Web site. Many people were even saying that no one would ever trust personal financial data to the Web. Today, you can take a picture of a check with your iPhone, deposit the check electronically and throw the physical check away. The convenience of electronic financial transactions via the Web far outweighed the security risks (both real and perceived).

I believe that we’re going through a similar transition with electronic health data that we went through with personal financial data back in the 1980s and 1990s. It may take a decade or two for people to be comfortable sharing their anonymized and aggregated medical information to benefit research…but maybe not. In my humble opinion, the benefits of portability of our medical information now far outweigh the security risks/concerns.

Some of the benefits are very pragmatic:

• Portability: When you switch doctors, you can bring your medical history with you electronically
• Accessibility: When you have an emergency and the ER team needs your history immediately and will want to search for all your allergies quickly
• Reference:When your doctor asks you when you had your last immunizations

You might recall that some high-profile early efforts at personal patient record systems failed ― specifically, Google Health and Microsoft HealthVault. I think of these not as failures, but as invaluable experiments that helped us all learn what works and doesn’t work in managing and sharing health data securely and efficiently. And perhaps most importantly, these experiments began to socialize the ideas of medical information being represented electronically and of patients owning their medical records.

Meet Project Green Button

Project Green Button is an important experiment in creating data liquidity and sharing medical information.

You may have heard of Project Blue Button. This was a fantastic project launched by the US Department of Veterans Affairs, enabling VA patients to download a copy of their own health data from the VA’s systems ― by clicking on a Blue Button. This is a really great example of empowering patients to own their own medical data and improving the portability of their medical information.

Now let’s think about it the other way around.

Research has suggested that if people were presented with a Green Button (see picture above) that provided a single-click way to share their data with researchers, more than 80% of people would press it. My close friend and trusted colleague John Wilbanks gave a great TED Talk about this a few months ago and has been doing ground-breaking work on open consent, the philosophy behind the Green Button.

I’m very hopeful that John will be successful in his mission to empower patients to share their own data to benefit research — after all, it is their data — and that most people, when asked, will be willing to share their anonymized information to benefit research.

The team at the LIVESTRONG Foundation, led by Director of Evaluation and Research Ruth Rechlis-Oekler, Ph.D, did a great study a few years ago about cancer patients’ and survivors’ willingness to share their information in the interest of improving research. The results were compelling: the majority of patients and survivors WERE willing to share their de-identified and aggregated health information with researchers in the interest of improving health care for others.

So, the willingness is there. All we are missing are the systems to enable this. And the time to create those systems (similar to what I described in my last blog post) is NOW. One of the most interesting companies working in this area is Avado; founder Dave Chase is one of the thought leaders in this space and has fantastic vision for where the industry needs to go over the next 10 years.

Wanted: A Trusted “Zone”

In order to prime the pump of online personal health data, we need patient-controlled solutions and a trusted zone where we can connect patients securely with their data. This trusted zone would be a place where:

• Each patient has a “dashboard” through which she can get access to all data about her own health, regardless of where the referential data is located
• Each patient can determine whether and with whom to share pieces of her health data, including her family doctor, relatives or loved ones
• Each patient can record and track her own health, records and experiences

The result would be something that feels like a simple dashboard: a single environment, available to the patient, where he can access, share, and manage all his relevant health information.

Once we can “free the data” in a trusted environment like this, it’s possible to bolt on a whole battery of cool apps that you can’t even anticipate today ― and that you don’t even have to develop yourself.

With today’s rapid app development technologies, we can build apps for physicians and for many other use cases, and simultaneously make the apps accessible via browser-based applications.

A great example is the LIVESTRONG Cancer Guide and Tracker for iPad, which collects and combines patient-reported data for patients living with cancer. We currently have a pilot project under way to connect the Tracker app with traditional clinical systems and a secure Web-based application, enabling the patient and his doctor to collaborate more effectively during office visits. We’re using the fantastic SMART Platform developed at Children’s Hospital in Boston under the leadership of Zak Kohane and Ken Mandl.

A Call to Action

So, here are a few action items:

First, we in the biopharmaceutical industry should ask ourselves: “What data can we ‘free up’ about our products and our studies to better support patients and physicians?” Let’s start with the basic inclusion/exclusion criteria for our existing studies that we already share with our clinical partners. As I mentioned in my previous post, if we would just increase the liquidity of this data in the biopharmaceutical industry, we could have a HUGE impact on the efficiency of research through the ability for the right patients to find the right studies at the right time.

Second, we should support the idea of open consent by supporting the Consent to Research project (http://weconsent.us/). Let’s all give the flexibility to patients to support research with their own medical information and, in the process, radically improve the efficiency of the healthcare system by simplifying the complex spider web of consents that our dysfunctional healthcare system has created. The current system of consents does not protect patients, but rather confuses them.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

Originally published at koablog.wordpress.com on November 27, 2012.

Open Patient Consent and Clinical Research Data was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

In my last two posts, I wrote about the need for more liquidity in clinical research data. As a foundation for sharing this new more-liquid clinical research data, we need more patient-centric systems, where patients can create, consume and maintain relevant medical information.

However, in the average hospital, most patient data is generated and organized in the clinic, and typically stored in a variety of different legacy hospital systems. Pretty illiquid by definition. Therefore, we need fresh approaches to sharing that data across hospital systems ― and then across multiple hospitals.

Fortunately, innovation in systems and software is beginning to happen on this front.

Several organizations ― including Dana-Farber Cancer Institute, the LIVESTRONG Foundation, and Boston Children’s Hospital ― are working to build a reference implementation. This is a technology model that would describe how a hospital could publish the information contained in its systems easily, securely and efficiently to other institutions.

Another very interesting technology is the SMART Platform, developed under the leadership of Dr. Zak Kohane and Dr. Ken Mandl at Children’s Hospital in Boston. The SMART Platform and i2b2 Analytical tool are truly a step in the right direction.

These new technical approaches provide the ability to build cool new apps very quickly — apps that combine data reported by the patient in an interface like the LIVESTRONG Cancer Guide and Tracker iPad app alongside data collected by traditional clinical systems. Using the same approach, we can build apps for physicians and many other use cases and simultaneously make the apps accessible via browser-based applications.

Let’s think about what else we can do as an industry — and encourage many people and companies to start writing new apps quickly.

In my next post, I’ll talk about big remaining challenge to the liquidity of clinical research data — patient consent — and how we win patient trust and cooperation.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

Originally published at koablog.wordpress.com on November 19, 2012.

Better Systems for Clinical Data Collaboration was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

To accelerate clinical research efforts for diseases like cancer, we need two things. First, stakeholder institutions (like biopharmaceutical companies and healthcare institutions) need to free up their data. Second, we need new systems and software that can share and manage that data — securely and at scale — across our complex healthcare ecosystem.

Start-ups are being formed every day that are pushing the envelope on applications and technologies that take advantage of health care data liquidity. In Boston/Cambridge alone, we have three start-up incubators dedicated to health information technologies, each with 10+ start-ups. That’s more than 30 top-tier, vetted start-ups focused on health information technologies being developed at any given point and time. For example, check out:

• Rock Health
• Health Box
• AthenaHealth Accelerator

Pharma companies have long been proponents of “free your data” — as long as it means freeing data from patients, from claims clearinghouses, from pharmacies and so on. Pharma companies have been less enthusiastic about freeing their own data, about their studies, clinical trials and drugs. But the logjam is starting to break.

As I mentioned in my previous post, recently GlaxoSmithKline (GSK) publicly announced it would make detailed data from clinical trials available to researchers. The company’s detailed patient data (data that forms the basis of trials of approved drugs as well as discontinued investigational drugs) would be made accessible to researchers. Researchers’ requests for access will be reviewed by an independent panel of experts, and the patient data will be anonymous.

Last year, one of the large biopharmaceutical companies — in collaboration with the electronic health record company Cerner — began an initiative to build an open interface that will enable sponsors of clinical research studies such as Novartis, Genentech, GSK or Pfizer to publish inclusion/exclusion criteria about their clinical studies to specific clinical partners — in much greater detail than what’s available on the National Institutes of Health‘s ClinicalTrials.gov today.

The goal of this project is to create a electronic mechanism to ensure that all eligible patients are identified for appropriate studies via their doctors. This mechanism would be able — without changing any data privacy — to flag patients’ records when they are diagnosed or when new studies or updates to studies become available; and to dynamically notify doctors and match patients with new or evolving studies based on patients’ clinical profiles and the inclusion/exclusion criteria of the trial.

Under this new electronic standard for study information, study eligibility criteria are expressed in a standardized, machine-readable format. Any EHR system can ingest the study data automatically as new studies are created and as existing studies change. With this more-liquid data, providers can then match the inclusion/exclusion criteria against the health records in their systems.

A provider configures its systems to flag records of potentially qualifying patients using a form of research-study-recommendation engine. The provider runs and tunes this engine so that the next time a clinician pulls up a patient’s health record (or the patient’s health record changes), the EHR system will suggest to the doctor that his patient may qualify for a clinical trial — both local and not-so-local trials (think truly global patient recruitment with little or no extra effort).

In addition, when a new trial is published, doctors with patients can be notified that there is a new trial of possible interest and eligibility for specific patients.

Through this type of simple standard for study information exchange — one that empowers doctors and is run by providers — doctors and patients could be automatically made aware of trials regardless of where the study is being run or when a new study starts.

Using this simple standard, Cerner has worked with various large biopharmaceutical companies to build and test end-to-end Proofs of Concept — in the process successfully demonstrating that this approach can work very well with relatively little extra effort on the part of the study sponsors, the providers or the biopharmaceutical companies. There is no additional risk of information privacy, since these criteria have been published previously to the providers, and the patient data does not have to be shared at all. The standard just enables getting better data on studies to providers in a more targeted way.

In short, starting to improve liquidity of clinical research data just requires leadership from pharma companies and cooperation from health care providers to prime the pump and adopt standards — and perhaps the encouragement of trusted brokers such as LIVESTRONG to bring the parties together.

Increasing the liquidity of data in ways like this could improve enrollment in studies, especially for rare diseases with small patient populations. Doctors and patients would have a proactive monitoring system that reminds them about all relevant research studies — especially new studies in rare indications — regardless of geography or the distractions in their daily lives.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

Originally published at koablog.wordpress.com on November 13, 2012.

Improving Data Liquidity in Clinical Research was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.

Much of the content in the next few posts was developed jointly with my close friend and trusted colleague Joris Van Dam. Joris is truly a superstar and is doing fantastic work around the world related to eHealth and improving the liquidity of data in healthcare.

In the course of creating new drugs and therapies, organizations in the biopharmaceutical and healthcare industries amass huge amounts of clinical trial data. Unfortunately, much of that data remains locked up in individual IT systems, making key data unavailable to the many of the participants in clinical trials: physicians and their patients. As our society intensely seeks cures for cancer and other diseases, this is nuts — and completely unnecessary. It’s time for a change. The data required to empower researchers can be shared securely and appropriately.

In the Information Age where we can do so much via the web, our smartphones, our iPads and the “Cloud,” we shouldn’t accept word of mouth as the best tool for patients to find the right studies. It’s clearly not. Nor should we accept data illiquidity as an obstacle to timely, broad availability of information about clinical trials.

The Story of Melissa

Meet Melissa. Melissa isn’t her real name and that isn’t her real picture above, but this is a true story.

Earlier this year Melissa was diagnosed with one of the deadliest forms of cancer. Despite her predicament, Melissa is one of those patients (like many of those involved in the LIVESTRONG community) who decided to take an active interest in her own care.

She wanted to proactively explore any and all kinds of treatment opportunities, including experimental treatment in a clinical research study.

Melissa was smart enough to understand that clinical trials offer no guarantee of improving her condition, let alone a cure. But the opportunity to participate in a clinical trial would give her hope. It would give her the ability to fight, and the satisfaction, that through her disease, she might be able to contribute to better treatment and ultimately perhaps even a cure, if not for herself then potentially for others like her. It would give her the feeling that her pain and suffering mattered and that she could make a difference in the world.

Melissa believed that it was important for her to have the opportunity to join a clinical research study. So she spent a lot of time on the Internet, educating herself about her disease and treatment opportunities. One day, using the U.S. National Institutes of Health’s Clinicaltrials.gov, she found a study for which she appeared to qualify ― one being run not too far from her home.

Unfortunately, Clinicaltrials.gov didn’t list the name or contact number for the investigative site. It just said that it was a study being run by a large biopharmaceutical company and that she could call the main switchboard number. She called and they really couldn’t help her ― so Melissa was stuck. Next, she turned to a clinical-trials matching web site and asked if there was anything they could do to help her.

Fortunately, by chance the team at the research group of the large biopharmaceutical company happened to know the person who runs that matching web site. That person connected Melissa with someone who offered to help coordinate.

The folks at the biopharmaceutical company went into their clinical trials database to identify the study manager. Then, they contacted the study manager, who went to the matching web site asking if it was okay to share their contact details with Melissa. A few weeks and many phone calls later, Melissa finally had a screening appointment at the clinic. Within a short time Melissa ― through her own perseverance and a lot of luck ― was screened and enrolled in the study.

Now the shocker in this story is that…

 ….the study investigator was Melissa’s own doctor!

This was the very doctor who had diagnosed Melissa just a few months earlier.

It’s tempting to think that this doctor dropped the ball. But in fact he hadn’t. He’s an extremely competent and compassionate physician, not to mention a great study investigator. He just had a lot going on, and the timing of the start of the trial had been off a bit with the timing of Melissa’s diagnosis.

It might also be tempting to say that the biopharmaceutical company was at fault for not listing the investigator’s contact details on Clinicaltrials.gov. But the clinic in question is based in Europe, where regulations are such that pharmaceutical companies have to obtain explicit consent from each individual investigative site before its contact details can be listed on Clinicaltrials.gov. The company just hadn’t dealt with all that red tape yet and there are no systems set up for information to flow more easily.

So, this situation was no one’s fault in particular, but rather a matter of circumstances, bad timing and the lack of data liquidity.

Time for Big Pharma and Healthcare Institutions to Step Up to the Plate

Clinicaltrials.gov was an important milestone and a catalyst when it was launched. On the back of clinicaltrials.gov emerged a slew of applications that help patients and doctors navigate the data, and find studies that are particular to a condition.

These include:

More recently, there are new smartphone apps such as TrialX and CoActive.

This is what data liquidity is all about: Making data appropriately available to encourage an ecosystem of applications that help patients and physicians ― and ultimately help drive down the cost of health care and improve outcomes.

But Clinicaltrials.gov was launched 12+ years ago ― 7 years before the first iPhone. We now need to go much further and faster in liberating clinical research data, and I believe that the large biopharmaceutical companies and healthcare institutions have the opportunity to take the lead.

GlaxoSmithKline (GSK) recently announced that it will open up access to its clinical trial data as appropriate to support open collaboration among researchers. (You can read more about this decision in this Wall Street Journal article here.)

To accelerate clinical research efforts, we also need new systems and software that can improve liquidity of clinical trial data across the complex healthcare ecosystem.

By increasing the liquidity of clinical trial data this way, we could both improve the lives of patients and reduce overall health care costs.

The information technologies exist. Attitudes toward information-sharing are changing. And cost reduction and better outcomes are compelling motivators.

In my next posts, I’ll talk about some specific initiatives that could have a big impact on the liquidity of data in the healthcare industry as well as a number of issues related to consent, where my great friend John Wilbanks is leading the charge. Check out his TED talk.

This blog post came out of a presentation that I recently delivered at Rev Forum, a conference sponsored by Lance Armstrong’s LIVESTRONG Foundation and Genentech. I have worked with LIVESTRONG and various biopharmaceutical companies on new health care information products and apps that take advantage of data liquidity to help patients combat cancer and other difficult diseases.

Originally published at koablog.wordpress.com on November 7, 2012.

The Need for Data Liquidity in Clinical Research was originally published in KoaLabs on Medium, where people are continuing the conversation by highlighting and responding to this story.